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Clinical Feature and Outcome of Angiographic Coronary Artery Disease in Chronic Kidney Disease Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00651521
Recruitment Status : Active, not recruiting
First Posted : April 2, 2008
Last Update Posted : March 10, 2020
Sponsor:
Information provided by (Responsible Party):
I Wen Wu, MD, Chang Gung Memorial Hospital

Brief Summary:

The prevalence and mortality rate of cardiovascular disease (CVD) in chronic kidney disease (CKD) patients is high. The prevalence of coronary artery disease (CAD) in CKD population ranges from 38 to 65%, with an average of 3.3 coronary lesions per person. The relative risk for death from myocardial infarction and CAD is 1.18 in CKD patients with GFR < 60 ml/min. Because of this high prevalence of CAD and its high mortality, reducing and preventing CAD risk factors is crucial in the clinical management of CKD patients.

Low glomerular filtration rate (GFR) constitutes an important independent risk factor for CAD. Several pathogenic factors play role in the genesis of cardiovascular dysfunction in chronic kidney disease. Increased traditional CAD risk factor, endothelial dysfunction, sympathetic hyperactivity, renin-angiotensin system activation, increased glycosylated end products, all contribute to the characteristic medial calcification of cardiovascular disease in CKD patients. Hypertension, fluid overloading and anemia further aggravated the cardiac loading, leading to myocardial hypertrophy with chamber dilatation, heart failure and death.

The mortality rate of CAD in CKD patients is extremely high. The NHANES II (National Health and Nutritional Evaluation Survey) found an increased of mortality rate> 51%, when the GFR decreased from > 90 to < 70 ml/min. The 1-year mortality rate in different CKD stage were 0.7% (normal renal function patients), 2.0% (patients with proteinuria), 3.5% (overt proteinuric patients) and 12.1% (dialysis patients), respectively. However, the clinical feature and outcome of CAD in different stage of CKD remains unclear.

We conducted a retrospective cohort study involving all patients admitted for coronary angiography from 1992 to 2004. The patients were categorized into five stages of CAD to compare the risk factor, clinical feature and outcome. Determination of this relationship can help to establish factors for early detection of CAD in CKD patients and also prognostic factor to improve outcome of these patients.


Condition or disease
Coronary Artery Disease Chronic Kidney Disease

Detailed Description:
All patients who underwent cardiac catheterization for assessment of CAD at Keelung Chang Gung Memorial Hospital between 1992 and 2004 with continuous serum creatinine values measured before admission were included in this analysis. Data were obtained from medical records of the database center of our institution. Demographic and clinical data were assessed. The age, sex, body mass index (BMI), body surface area (BSA), underlying comorbidities, CAD risk factors (including diabetes mellitus, hypertension, dyslipidemia, smoking, and obesity, defined as a BMI > 30) and clinical presentation were included in this study. Hemodynamic parameters including the systolic and diastolic blood pressure, heart rate and left ventricular ejection fraction were also obtained. Coronary angiography was performed using a low-osmolarity non-ionic contrast medium (iodixanol) by experienced cardiologist. Coronary artery disease was defined as a 50% or greater lumen narrowing of a major epicardial artery or its branches. A left main stenosis of 50% or greater was regarded as equivalent to 2-vessel disease. Blood samples were collected during admission before angiographic procedure. Values of hemoglobin, white blood cells, platelet, high sensitivity C-reactive protein (hs-CRP) and troponin I was included. The treatment modality was divided into three categories: medical, percutaneous coronary intervention (PCI, including balloon angioplasty with or without stent placement) and coronary artery bridge graft (CABG) on the basis of clinical condition and angiographic finding. The outcome was followed-up until 12 months after angiographic procedure. The estimated total study patient number is approximately 1000 patients.

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Study Type : Observational
Actual Enrollment : 1000 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Clinical Feature and Outcome of Angiographic Coronary Artery Disease in Chronic Kidney Disease Patients
Study Start Date : April 2009
Estimated Primary Completion Date : March 2022
Estimated Study Completion Date : March 2025

Resource links provided by the National Library of Medicine


Group/Cohort
1
CKD stage 1 patients
2
CKD stage 2 patients
3
CKD stage 3a patients
4
CKD stage 3b patients
5
CKD stage 4 patients
6
CKD stage 5 patients



Primary Outcome Measures :
  1. all cause death [ Time Frame: 10 years ]
    number of death

  2. change of renal function [ Time Frame: 10 years ]
    number to dialysis



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
All CKD patients admitted for coronary angiography from 1992 to 2019. The patients were further categorized into five stages of CKD.
Criteria

Inclusion Criteria:

  1. CKD patients with typical angina or positive electrocardiographic finding for myocardia ischemia.
  2. Aged 20-80 years.

Exclusion criteria:

1. recipient of renal transplant graft or dialysis therapy


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00651521


Locations
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Taiwan
Department of Nephrology,Chang Gung Memorial Hospital
Keelung, Taiwan, 240
Sponsors and Collaborators
Chang Gung Memorial Hospital
Investigators
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Principal Investigator: Iwen Wu, MD Chang Gung Memorial Hospital
Publications:

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Responsible Party: I Wen Wu, MD, Attending physician, Chang Gung Memorial Hospital
ClinicalTrials.gov Identifier: NCT00651521    
Other Study ID Numbers: IWW-0002
CGMH-IRB-96-1680B
First Posted: April 2, 2008    Key Record Dates
Last Update Posted: March 10, 2020
Last Verified: March 2020
Keywords provided by I Wen Wu, MD, Chang Gung Memorial Hospital:
Angiographic CAD
Chronic kidney disease
Left ventricular dysfunction
Body mass index
Cardiovascular mortality
Coronary angiography
Additional relevant MeSH terms:
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Kidney Diseases
Renal Insufficiency, Chronic
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Urologic Diseases
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Renal Insufficiency